Based on age, gender, genetic background, lifestyle and other health risk factors, people generally have health problems and chronic illnesses at different points in their lives. Some of the risk factors are modifiable. By intervening appropriately to reduce the modifiable risk factors, we can improve overall health outcomes, delay or even prevent the onset of diseases, and thus reduce healthcare expenses. The reduction in healthcare expenses represents savings for organizations that pay for the healthcare services.
According to this invention, the key to reducing health risks is improving medical adherence (defined above). Since treating diseases in their early stages is much more effective and cheaper, proper screenings can reduce costs by detecting emergent diseases before they become overt problems. For people who have not been diagnosed with any disease, but may be at risk, the objective is to keep them healthy by improving their participation in wellness and prevention programs. These programs delay or even prevent the onset of chronic diseases. Once diseases have taken root, however, wellness and prevention are not enough; medications or treatments become necessary to keep diseases under control. Thus, for people who have been diagnosed with disease(s), the objective is to retard or prevent the natural progression of the disease(s) by improving their medication or treatment adherence, in addition to improving their participation in wellness and prevention programs.
Medication adherence is characterized in terms of what the patient does after receiving a prescription from the doctor or nurse. Studies show that around 14 percent do not even fill the prescription at a pharmacy, and overall medication adherence is only around 50 percent. Medication non-adherence takes place in various modes: missed drug, wrong drug, missed dose, wrong dose, or wrong time. Any of these modes would make the drug-taking different from the controlled conditions of the clinical trial under which the drug's efficacy has been established. Thus the patient, taking the drugs in these non-adherence modes would not experience the expected health outcomes to the same level of effectiveness.
There are several reasons why medication adherence is so low. According to a detailed study of non-compliance, patients: (1) forget, (2) cannot get prescriptions filled or delivered, (3) do not want the side effects, (4) cannot afford the drug, (5) do not think they need the drug, or (6) do not know how to use the drug. Other cited reasons include personal feelings or beliefs, such as: (1) “I don't have symptoms”, (2) “I feel fine”, (3) “I am not convinced I need the drug or of the drug's benefit”, (4) “It can't happen to me”, (5) “I am afraid to take the drug because of adverse effects”, (6) “the side effects are too uncomfortable”, (7) “I can't remember to take the drug”, (8) “The drug is too expensive”, (9) “I think my health problem has been fixed”—and discontinue drugs as soon as they feel better, or (10) “If more is better, let me increase the dosage to speed up the cure”.
Current interventions predominantly address a particular singular reason for non-adherence. For example, there are several ‘reminder’ services that automatically send a voice or SMS message to the individual's cell phone at the appropriate times of day to remind him or her to take their medicine. This is very useful for individuals who tend to forget, but only an irritant for those who are quite regular and don't forget. Another example is the suspension, by health plans, of co-pay or co-insurance for drugs that are used to control certain diseases, such as diabetes, in an effort to get individuals to at least fill their prescriptions (the hope is that they will later take the medicines as prescribed). This may help diabetics who are currently not filling their prescriptions because of cost considerations, but it may not be necessary for diabetics who can afford the copays and were going to fill their prescriptions anyway. Further, this only removes the cost barrier for diabetics to fill their prescriptions. It does not necessarily influence or enable them to take them as prescribed, at the right times and dosage strengths. In addition, there is no feedback loop to confirm that individuals are indeed taking the drugs as prescribed. A combination of the above two interventions might be quite effective for diabetics who not only have financial constraints that keep them from filling their prescriptions, but also tend to be forgetful. Thus, even with two potential interventions, we can see that the effective applicability can be quickly narrowed down to a small subset of individuals.
In general, there are hundreds of potential interventions and each intervention only works for a small segment of the population, at a particular time, so any single intervention will only have a small impact on overall adherence. This invention seeks to overcome this drawback by first selecting appropriate interventions based on the individual's needs and preferences, then personalizing the interventions, and further adapting the interventions as the individual's needs change. An individual's needs change with the natural (uncontrolled) progression of medical conditions over time, starting with a ‘healthy, but at-risk’ phase towards an ‘early signs or symptoms’ phase, followed by a ‘diagnosis’ phase, and, if diagnosed, a subsequent ‘treatment and follow-up’ phase. If left uncontrolled, some medical conditions may progress towards complications, disabilities and even death. At each phase, the individual needs to act in different ways.
There are yet other reasons for poor adherence, and these are very specific to individual patients. In terms of the ‘State of Health’, the reasons for non-adherence are different depending on the disease, whether it is hypertension, high cholesterol, depression, diabetes, multiple sclerosis, and so on. In terms of the ‘Health Beliefs’, adherence depends a lot on the patient's perceived susceptibility, severity, barriers, benefits, cues to action, trust in doctors, trust in medicines, and so on. In terms of behavioral ‘Stage of Change’, much depends on whether patients acknowledge their health issues or are in denial; specifically on whether they are in ‘Pre-contemplation’, ‘Contemplation’, ‘Decision’, ‘Action’, or ‘Maintenance’ stages. Following a diagnosis, patients may go through the stages of ‘Denial’, ‘Anger’, ‘Bargaining’ and ‘Depression’ before finally ‘Accepting’ that they have the diagnosed condition and that they need to actively seek and adhere to proper medical treatment.
Demographics also play a key role; age, gender, race, income, family size, family arrangements, education, and so on have an impact on the level of adherence. Personal factors, such as caregiver availability, type of job, hobbies, travel patterns, daily commute, personality type, inertia level, desire for secrecy and peer influences, enter into the picture as well.
These reasons are not only very specific to individuals, but they also vary over time for the same individual, since at any particular time, the individual is subject to various situational factors. These factors interact with the individual's current behavioral state and health beliefs, and produce a current level of receptivity to specific types of influences and information. Given this, merely transmitting pre-planned messages, even if they are somewhat personalized, has a reduced chance of being received and acted upon by the subject individual. If the individual does not consider the message or content to be relevant or of value, he or she may simply ignore it, or worse, tend to ignore subsequent messages from the same source—this is all well-known. It is also well known that individuals' receptivity and response to interventions improves when the number of interventions at any time is small. Faced with a large list of ‘things to do’, over long periods of time, as is the case with many web sites or services that deal with specific medical conditions, individuals find it difficult to decide which action to perform at any time, and end up procrastinating or doing things that are easier but not necessarily effective. The chances of getting the individual to act effectively are much higher if he only has to perform a few actions, over the course of a given day. Accordingly, in order to maximize the chances of being received and acted upon, a main goal of this invention is to provide timely interventions that are highly personalized, relevant and matched to each individual's current medical and behavioral stage, and also organized by daily, weekly, monthly, or other user-specified time windows, in an effort to present the smallest number of the most actionable interventions at any particular time.
Effecting change in behavior, such as going for health screenings, participating in wellness activities or medicine-taking, requires a consistent set of messages to get through to the subject individual for a certain length of time, at a frequency that keeps the messages from being forgotten. Studies on memory formation and forgetting are useful in setting the intervention frequency, and the often-cited cybernetic view that it takes three to four weeks for a new habit to develop is also useful in setting the duration of interventions. Thus not only do the interventions (that convey the messages) have to be highly personalized, relevant and matched to the current medical and behavioral stages, they must also be provided at a frequency that maximizes the likelihood of being received and not ignored. If the interventions are too frequent, the individual may turn them off, considering them a nuisance. On the other hand, interventions that are too infrequent have limited or no effect in changing the behavior. Interventions must provide some value to the individual, such as imparting interesting information, pointing them to useful hints and tips, and so on. Also, the content must be fresh and engaging—the same content repeated multiple times loses the effect. Accordingly, another goal of this invention is to select the interventions such that relevant, but possibly different, content is provided at different times. Yet another goal is to match the frequency of the interventions to the individual's preferences at a particular time.
Personalization of interventions based on static knowledge about the individual is a good starting point, but the impact is rapidly lost if the personalization is not refreshed based on the individual's response. Continuing to send interventions similar to those that have been ignored or dismissed by the individual serves no useful purpose and may even alienate the individual. On the other hand, avoiding these interventions can help. Modeling future interventions around those to which the individual has responded positively, is more likely to sustain the interest and level of engagement of the individual. Accordingly, a goal of this invention is to seek individual responses to interventions, in terms of usefulness, relevance, value etc., and to use these responses to model and adapt further interventions.
Existing approaches to improve adherence in general do not concern themselves with what happens after the patient fills the prescription; in other words, adherence equals ‘possession’. However, what matters to good health outcomes is not whether the patient fills the prescription, but whether the patient actually takes the medication as prescribed. Accordingly, this invention seeks to improve adherence in terms of how well the patient follows the prescription, i.e., whether the right drug was taken at the right time, at the right dosage, and whether all the prescribed drugs were taken.
Some approaches provide interventions in the form of a one-time plan generated on the basis of static information about the patient. The patient is required to perform the activities in the plan, and there are periodic (e.g. quarterly) follow-ups. Issues of cost due to the reliance on physical mailings or expensive nurse labor may dictate this infrequent follow up. It is known that interactive and frequent interventions work better, so while these approaches are getting some results, much better results are possible with more frequent and personalized follow up. This invention, as mentioned previously, seeks to provide interventions frequently enough to change behavior, but limits the frequency to individual patient preferences in order to minimize the chances of being ignored.
Another drawback is that currently available interventions are not frequent or granular enough to enable individuals to take specific and timely actions. They periodically advise individuals by means of a list of various activities they need to perform, but do not provide an adequate framework for decision-making (‘decision support’) or action-planning (‘action support’). The individual has to separately research each item on the list in order to decide on which activities to perform and within what timeframe, and then has to break the activities down to actionable tasks to perform the selected activities. For example, if the activity is to ‘get a cholesterol screening’, the actionable tasks may be: (a) making an appointment, (b) fasting before the appointment, (c) going for the appointment, (d) obtaining the screening results, etc. It is typically up to the individual to break each activity into such actionable tasks and remain vigilant in order to make sure that the tasks are being performed in a timely manner. All this imposes a large burden, especially for working individuals whose busy schedules leave little room for this sort of vigilance and perseverance; as a result, they frequently fail to perform their required health-related tasks. In other words, individuals are expected to remember and take a number of health related actions on a daily, weekly, monthly, quarterly and annual basis, but with very little by way of day-to-day support. One of the aspects of this invention is that it provides the necessary day-to-day ‘hand-holding’ support that enables individuals to perform the required health related tasks in a timely manner.
Individuals with multiple chronic medical conditions or susceptibilities are required to perform a number of regularly scheduled health-related actions on a daily, weekly, monthly, quarterly or annual basis in order to keep their conditions under control. They interact with medical professionals for a very small fraction of the time, during which they are instructed about these actions, but are pretty much ‘on their own’ for the majority of the time during which they have to take these actions. Typically, individuals cannot recall much of the instructions even after a day or two, so it is very difficult to remember them on a long-term basis. There is a need for a way to help individuals find out what actions they should be taking, to help them decide which actions to take immediately (‘decision support’) and to assist them in actually performing these actions (‘action support’) on a day-to-day basis. There is a need for far greater granularity in identifying the actions than is provided by existing interventions. This invention provides a health action calendar on a daily, weekly, monthly, quarterly, annually or individually specified periodic basis, in order to inform the individual about various actions in different timeframes. Further, this invention provides detailed information, relevant to each action, in order to assist the individual to ‘learn more’, understand ‘why do it’ and see instructions on ‘how to do it’, as well as ‘what to ask the doctor’, and so on, in an attempt to help individuals make decisions about performing specific actions. Information about relevant products and services may also be provided, all in the same user interface.
Such detailed information in the categories of ‘learn more, or ‘how to do it’ etc., are provided on many web sites, using clickable links to the information—these links are typically static urls that can be deleted or changed or otherwise become inaccessible over time because they are maintained by third parties. This requires continued investment, in the form of constant vigilance and maintenance of these links. The present invention is novel in the way in which the detailed information is displayed—links to detailed information are dynamically retrieved, created and presented to the individual, in real time. This is done using pre-configured search words associated with the specific action and information category. The search words are passed to free web search engines (e.g. Google, Yahoo, etc.), and the search engines return the search results, or dynamic links, which are summarized and displayed in the user interface. Upon clicking on any of the dynamic links, the system opens a browser window and displays the detailed information. Thus there is no need for any investment in maintaining any links since the relevant and up to date detailed information is retrieved from the web upon clicking on any of the dynamic links. Links to ‘certified’ or ‘trusted’ or ‘custom’ content can also be provided in a similar manner.
Yet another drawback of existing approaches is that the emphasis is on ‘telling’ the patient what to do, but not sufficiently ‘motivating’ the patient to take charge of their own health. ‘Telling’, especially in strong terms indeed has an impact on adherence, but it disappears soon after the intervention is removed. Change in behavior resulting from being motivated has a sounder basis and thus has a better chance of maintaining itself as circumstances change. Accordingly, another goal of this invention is to first understand the ‘stage of change’ of an individual in terms of target health behaviors (such as medicine-taking or going for health screenings or participating in weight-loss or smoking-cessation programs), then construct a personalized intervention plan. Individuals progress serially through the stages of: (a) pre-contemplation, when they are not even thinking about the target action, to (b) contemplation, when they have begun to consider the target action, to (c) decision, when they are making a decision about taking the target action, to (d) action, when they are actually taking the target action, to (e) maintenance, when they are continuing to take the target action on a regular basis. At any stage, individuals can revert to a previous stage (such as in a relapse), and the progression is restarted from the reverted-to stage. As an example, if an individual is not even contemplating going for health screenings, he needs to be influenced to do so, using interventions with compelling content designed to increase his awareness of screenings, and his perception of susceptibility to disease because of age, gender, ethnicity, lifestyle, etc. The objective is to move the individual to the point of contemplating screenings; once this objective is achieved, a different set of interventions might serve to move the individual to the subsequent decision-making stage, and so on. Thus by using different sets of interventions targeted at different stages of change, the individual is moved forward (i.e. motivated) towards self-efficacy. Accordingly, a key objective of this invention is to progressively ‘activate’ the individual into taking specific health actions on a regular basis.
An individual may not respond sufficiently to interventions; when this happens, it is necessary to escalate the content in an attempt to increase the urgency or awareness of severity in an attempt to improve responsiveness. A different set of interventions, featuring content designed to increase his perception of seriousness, e.g., what can happen if he lets a condition to progress uncontrolled for too long, and so on. A good example of content in this regard is the TV commercial of a young man who has gone blind because he neglected getting screened for diabetes. Another goal of this invention is to provide a method by which interventions are escalated automatically, based on member response or non-response, through one or more levels. For example, a non-response to an intervention may initially be escalated, after a certain elapsed time, to an alternate contact; on continued non-response, it may be escalated to an authorized caregiver; on further continued non-response, an exception may be generated, and the physician, pharmacist or other authorized provider may be alerted so that proactive measures may be taken, such as a personal phone call for coaching or triage intervention.
Interventions that involve personalized, human-interactions with individuals have so far been the most successful of the different approaches in current use—nurses or other qualified persons contacting individuals by phone or email on a regular basis to ask questions about heath, symptoms, side effects, adverse effects and so on. Coupled with these questions is some motivational interviewing designed to improve medication or treatment adherence. Due to the high cost of nurse-labor, these interventions are reserved for the sickest patients who might otherwise end up in the emergency room or hospital, and are not made available to the moderately-ill or healthy population. Additionally, a very large number of nurses would be needed to handle the latter population, at a time when there is a significant national nursing shortage, which makes this type of labor-intensive interventions impractical—it is inherently non-scalable to large populations.
Existing approaches to improving health can be categorized into: (1) nurse-labor-intensive, highly personalized ‘case management’ interventions for the highest-risk patients, (2) marginally personalized mass-produced ‘disease management’ interventions for the lower-risk patients, and (3) voluntary, self-service ‘wellness management’ programs for the healthy population. The highly personalized interventions have been shown to work well, and will likely do so for the lower-risk and healthy populations in improving medical adherence. However, because of the dependence on skilled nurse labor, these interventions are both expensive and non-scalable for these populations.
There is thus a need for an approach that can: (1) provide deeply personalized and motivational decision support and action support, (2) frequent interventions at low cost, and (3) be scaled-up to service the demands of a large population of healthy and medium-risk patients. This approach would keep the medium-risk patients from deteriorating towards high-risk and the healthy population from deteriorating towards medium risk. The objectives of this invention are to address these needs. Doing so would significantly reduce the estimated $100 billion annual costs of treating medical problems due to non-adherence in the US alone. In addition, improving adherence would recapture some of the $30 billion worth of unfilled prescriptions every year, and thus increase pharmaceutical industry revenues. Accordingly, a key goal of this invention is to provide a deep level of personalization and adequate frequency in the interventions, but at greatly reduced cost, through automation. A further goal is to eliminate the barriers to scalability, also through automation using readily available personal devices such as cell phones, as opposed to distributing special purpose devices.
U.S. Pat. No. 5,642,731 monitors the disease process and health of a patient undergoing drug treatment by using a microprocessor embedded in a drug dispenser to record a variety of clinical information such as symptoms, side effects, adverse drug reactions and so on. It seeks to improve disease management by capturing the date and time of the dosage, analyzing the data and downloading instructions to alter patient behavior in taking medication. This invention mechanizes the recording of when patients are opening the medication containers to ostensibly take their medicines, as well as the recording of clinical information, so it addresses the need for recording actual adherence. However, it does not address the motivational issues around taking the medications—patients may take the medicine as long as this invention is present and stop thereafter, or they may go through the motions of opening the container but not actually ingest the medications. Further, they may not accurately enter all the information required.
U.S. Pat. Nos. 6,234,964 and 6,770,029 describe a system that performs disease management in a fully automated manner using periodic interactive dialogs with the patient to obtain health state measurements, to assess the patient's disease and adjust therapy, and to give the patient medical advice. They also describe features and a metric based on subjective and objective health measurements that are used to tailor disease management interventions to individual patients. The system builds a profile of the frequency and patient's reasons for using the system, understanding of the disease, response to various treatments and preferences. The system interacts with patients through regularly scheduled sessions. This invention automates the traditional approach to following up on patients with chronic diseases—gauging health status, risks, clinical results, etc. and developing therapy-oriented intervention plans.
U.S. Pat. No. 6,974,328 describes an adaptive interactive teaching system for the remote education that selects and provides lessons based on a patient's profile. The lessons offer the patient information reflecting the patient's health, and offers the patient's healthcare provider information regarding the patient's study of the lessons, the patient's health, and the patient's medical appointments.
US Patent Application 2002/0169635 (Shillingburg) uses a custom device for transmitting messages, whereas the present invention uses cell phones or PDAs or whatever devices the individual already possesses, and requires no distribution of special hardware. The custom device described in the above application also has storage compartments for dispensing medication at the proper time. Adherence is measured in the above application by means of recording the time of opening of the medication compartment. The technical act of measurement described in the above application provides little by way of motivational value, whereas the ‘self-report’ technique is inherently designed to motivate the individual to improve adherence. The drawback is that self-reporting over-estimates adherence, but the motivational value, over time, is expected to reduce the over-estimation.
In general, the above-mentioned examples address specific parts of the overall problem and are lacking in the depth of personalization, matching to individual health states, frequency of intervention, obtaining and incorporating feedback from members and in adapting to the changing needs of the individual members. The system described hereafter introduces novel elements and builds on some of the existing solutions, or parts thereof, and provides a more comprehensive solution.